(185 days)
Not Found
No
The description focuses on programmable electronic control of a syringe, not on learning or adaptive algorithms. The "Not Found" entries for AI/ML mentions and training/test data descriptions further support this.
Yes
The device is used for the injection of local anesthetics for infiltration and nerve block anesthesia, which are medical treatments for pain.
No
The device is described as an injection device for local anesthetics, not a device for identifying or characterizing a disease or condition.
No
The device description explicitly states it consists of a "programmable control unit" and a "handpiece with switches," indicating physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures." This describes a procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a "programmable electronic device that allows the injection of local anesthetics." This further reinforces its function as a delivery system for medication within the body, not a diagnostic tool analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the administration of medication.
N/A
Intended Use / Indications for Use
Indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.
The CCS Computer Controlled Syringe is an electronic programmable device indicated for the injection of local anesthetics for infiltration and nerve block anesthesia administered prior to, or in conjunction with, dental procedures.
Product codes
EJI
Device Description
The CCS computer controlled syringe is a programmable electronic device that allows the injection of local anesthetics commercially available and packaged in cartridge form. The device consists of a programmable control unit, and a handpiece with switches that actuate the function of the device as programmed. Single use, replacement cartridge holders are available to facilitate universal injection technique.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data is presented in the 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
K98 3105
9.0 Summary of Safety and Effectiveness
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA, 1990.
| Submitted by: | CCS Inc.
5 Oxford Street West, London, Ontario, Canada. N6H 1R1
Phone 519-672-1190 Fax 519-672-8557 | |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Prepared by: | CATCO:Competitive Advantage Tools Company
2288 Yorktown Circle, Mississauga, Ontario, Canada. L5M 5Y2
Phone 905-819-9425 Fax 905-819-9562
Steve Long, President | |
| Date: | August 31, 1998 | |
| Trade Name: | CCS Computer Controlled Syringe
CCS Cartridge Holder | (Model CCS-100)
(Model CCS-100-01) |
| Classification: | Class II. 21 CFR 872.6770 | |
| Predicate Device: | The Wand (K961648) | |
| Device Description: | The CCS computer controlled syringe is a programmable electronic
device that allows the injection of local anesthetics commercially
available and packaged in cartridge form. The device consists of a
programmable control unit, and a handpiece with switches that actuate
the function of the device as programmed. Single use, replacement
cartridge holders are available to facilitate universal injection technique. | |
| Intended Use: | Indicated for the injection of local anesthetics for infiltration and nerve
block anesthesia administered prior to, or in conjunction with, dental
procedures. | |
| Sterility: | The described devices are non-sterile. | |
| Performance Data: | Performance data is presented in the 510(k) submission. | |
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with three lines representing its wings and a human profile in the negative space below the wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 8 1999
Computer Controlled Syringe, Incorporated C/O Mr. Steve Long President CATCO:Competitive Advantage Tools Company 2288 Yorktown Circle Mississauga, Ontario, CANADA L5M5Y2
Re : K983105 CCS; Computer Controlled Syringe, Model Trade Name: #CCS-100, CCS; Cartridge Holder, Model #CCS-100-01 Regulatory Class: II Product Code: EJI February 18, 1999 Dated: February 22, 1999 Received:
Dear Mr. Long:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
2
Page 2 - Mr. Long
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
. Page 1 of 1
510(k) Number (if known): K983105
Device Name: CCS
Indications For Use:
The CCS Computer Controlled Syringe is an electronic programmable device indicated The OCS Computer Controller of the infiltration and nerve block anesthesia for the injocular of lead an conjunction with, dental procedures
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number . 3100
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)